Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase
Observational
Started
2024-07-30
Last updated
2024-07-26
Condition(s) studied
BPSD (Behavioral and Psycological Symptoms of Dementia)Alzheimer's Dementia
Investigational drug(s) / intervention(s)
Electroacupuncture treatment
Electroacupuncture treatment: Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
Study summary
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Meet the diagnostic criteria for AD in the NIA-AA standard;
2. Clinical dementia rating scale ≤2 points;
3. Accompanied by at least one psychobehavioral symptom, NPI:frequency × degree ≥1 point;
4. Sign informed consent.
Exclusion Criteria:
1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
Primary outcome measure(s)
Neuropsychiatric Inventory (NPI) — NPI will be performed before treatment and every month after treatment for up to 24 months NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is.
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) — The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms.
Trial sites (7)
Facility
City
Region
Status
Beijing United Family Rehabilitation Hospital
Beijing
Beijing Municipality
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing
Beijing Municipality
Xuanwu Hospital of Capital Medical University
Beijing
Beijing Municipality
Beijing Geriatric Hospital
Beijing
Beijing Municipality
Fujian University of Traditional Chinese Medicine
Fuzhou
Fujian
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin
Heilongjiang
More Guang'anmen Hospital of China Academy of Chinese Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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